Drug FDA Class I Ongoing Failed specifications

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

Astellas Pharma US Inc. Published Feb 5, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Astellas Pharma US Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Hazards

Empty Capsules · primary

Affected products (1)

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

PROGRAF · 14,340 100-count bottles

NDC: 0469-0607, 0469-0617, 0469-0657, 0469-3016, 0469-1230, 0469-1330, 0469-0607-73, 0469-0617-73, 0469-0617-11, 0469-0657-73, 0469-0657-11, 0469-3016-01, 0469-1230-50, 0469-1330-50

Lot codes: 0E3353D

Code info: Lot# 0E3353D, Exp 03/31/2026

Affected areas

Nationwide

Timeline

Initiated

Dec 23, 2024
Published

Feb 5, 2025

Recall number: D-0211-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.